Brief Summary

Obstructive Sleep Apnea (OSA) is characterised by repetitive collapse of the upper airway during sleep, inducing breathing disturbances that can result in oxygen desaturation and frequent arousals. In children, OSA can have long-term consequences on the development and on the cardiovascular system. Down Syndrome (DS) is a genetic disorder associated with intellectual disability and many comorbidities. The prevalence of OSA is particularly high in patients with DS, from infancy. In a recent study, OSA was diagnosed in 97% infants and early diagnosis and intervention from the age of 6 months was associated with better neurocognitive outcome at 3 years old. Therefore, there is a need to develop new strategies to prevent OSA early in infancy. OSA can be linked to some orofacial abnormalities presented by patients with DS. Indeed, orofacial functions and structures ca play a crucial role in OSA. For example, nose breathing allows the tongue to act as a stimulator of the transverse maxillary growth during childhood, allowing the upper airway to develop properly. The primary objective of the present study is to evaluate the effects of a pacifier used by infants with Down Syndrome (from the age of 1 months) on the severity of OSA at the age of 6 months, by comparing a group of infants with the pacifier vs a group of infants without the pacifier. The main hypothesis is that infants who used the pacifier from 1 month- to 6 month-old will have lower OSA severity (estimated by the obstructive apnea hypopnea index on polysomnography (PSG)).

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

30mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.5 years study duration

Study Progress4%

Jul 2026Jan 2029

First Submitted

Initial submission to the registry

May 20, 2026

Completed

29 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed

13 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

2.5 years

First QC Date

May 20, 2026

Last Update Submit

June 16, 2026

Conditions

Obstructive Sleep Apnea Down Syndrome (Trisomy 21)

Keywords

Sleep apneaDown syndromeOro-myo-functional developmentSleepNon-nutritive suckingPacifier

Outcome Measures

Primary Outcomes (1)

Obstructive apnea hypnopnea index
OAHI (/h) will be measured by PSG. Night PSG will take place during a 24h-stay at the hospital when infants are 6 months old.
Month 6

Secondary Outcomes (16)

Pulse wave amplitude drop (PWAD)
Month 6
Hypoxic burden
Month 6
Mandibular movements index
Month 6
OSA severity class
Month 6
Frequency of sucking bursts (/min)
Month 6
+11 more secondary outcomes

Study Arms (2)

Infants with Down Syndrome without CURAPROX pacifier

NO INTERVENTION

Infants with Down Syndrome, included in the study OMF21 (age: 6 months), who did not use the CURAPROX pacifier

Infants with Down Syndrome with the CURAPROX pacifier

EXPERIMENTAL

infants with Down Syndrome with the pacifier

Device: CURAPROX pacifier useOther: Pacifier diaryDiagnostic Test: Polysomnography (PSG) to explore OSAOther: Non-nutritive sucking recordingOther: Oro-myo-functional clinical evaluationBehavioral: Neurocognitive evaluationOther: Sleep Disturbance Scale for ChildrenOther: Sleep Hygien Scale for ChildrenOther: PedsQL-Infants

Interventions

CURAPROX pacifier useDEVICE

The CURAPROX pacifier is a biofunctional pacifier developed to promote nasal breathing and a healthy oro-facial development, available for sale to the general public. It will be given to infants when they are 1 month old, until the last visit at 6 months.